NDC 63361-243
VAXELIS
Diphtheria And Tetanus Toxoids And Acellular Pertussis, Inactivated Poliovirus, Haemophilus B Conjugate And Hepatitis B Vaccine
VAXELIS is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Mcm Vaccine Co.. The primary component is Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated); Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated); Bordetella Pertussis Toxoid Antigen (glutaraldehyde Inactivated); Bordetella Pertussis Filamentous Hemagglutinin Antigen (formaldehyde Inactivated); Bordetella Pertussis Pertactin Antigen; Bordetella Pertussis Fimbriae 2/3 Antigen; Poliovirus Type 1 Antigen (formaldehyde Inactivated); Poliovirus Type 2 Antigen (formaldehyde Inactivated); Poliovirus Type 3 Antigen (formaldehyde Inactivated); Hepatitis B Virus Subtype Adw Hbsag Surface Protein Antigen; Haemophilus Influenzae Type B Capsular Polysaccharide Meningococcal Outer Membrane Protein Conjugate Antigen.
| Product ID | 63361-243_153c5767-222d-4eff-8f11-bea7071a6ba2 |
| NDC | 63361-243 |
| Product Type | Vaccine |
| Proprietary Name | VAXELIS |
| Generic Name | Diphtheria And Tetanus Toxoids And Acellular Pertussis, Inactivated Poliovirus, Haemophilus B Conjugate And Hepatitis B Vaccine |
| Dosage Form | Injection, Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2018-12-21 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125563 |
| Labeler Name | MCM Vaccine Co. |
| Substance Name | CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN; HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN |
| Active Ingredient Strength | 15 [Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; ug/.5mL; ug/.5mL |
| Pharm Classes | Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Diphtheria Toxoid [CS],Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Tetanus Toxoid [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [CS],Vaccines, Inactivated [CS],Pertussis Vaccine [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pertussis Vaccine [CS],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [CS],Vaccines, Inactivated [CS],Actively Acquired Immunity [PE],Haemophilus Vaccines [CS],Inactivated Haemophilus Influenzae B Vaccine [EPC],Vaccines, Inactivated [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 63361-243-10
10 VIAL, SINGLE-DOSE in 1 PACKAGE (63361-243-10) > .5 mL in 1 VIAL, SINGLE-DOSE (63361-243-58)
| Marketing Start Date | 2018-12-21 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 63361-243-58 [63361024358]
VAXELIS INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA125563 |
| Product Type | VACCINE |
| Marketing Start Date | 2018-12-21 |
NDC 63361-243-10 [63361024310]
VAXELIS INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA125563 |
| Product Type | VACCINE |
| Marketing Start Date | 2018-12-21 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) | 15 [Lf]/.5mL |
Pharmacological Class
- Inactivated Corynebacterium Diphtheriae Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Vaccines
- Inactivated [CS]
- Diphtheria Toxoid [CS]
- Inactivated Clostridium Tetani Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Vaccines
- Inactivated [CS]
- Tetanus Toxoid [CS]
- Inactivated Bordetella Pertussis Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Pertussis Vaccine [CS]
- Vaccines
- Inactivated [CS]
- Pertussis Vaccine [CS]
- Inactivated Bordetella Pertussis Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Vaccines
- Inactivated [CS]
- Inactivated Bordetella Pertussis Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Vaccines
- Inactivated [CS]
- Pertussis Vaccine [CS]
- Inactivated Poliovirus Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Poliovirus Vaccines [CS]
- Vaccines
- Inactivated [CS]
- Inactivated Poliovirus Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Poliovirus Vaccines [CS]
- Vaccines
- Inactivated [CS]
- Inactivated Poliovirus Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Poliovirus Vaccines [CS]
- Vaccines
- Inactivated [CS]
- Inactivated Hepatitis B Virus Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Hepatitis B Vaccines [CS]
- Vaccines
- Inactivated [CS]
- Actively Acquired Immunity [PE]
- Haemophilus Vaccines [CS]
- Inactivated Haemophilus Influenzae B Vaccine [EPC]
- Vaccines
- Inactivated [CS]
NDC Crossover Matching brand name "VAXELIS" or generic name "Diphtheria And Tetanus Toxoids And Acellular Pertussis, Inactivated Poliovirus, Haemophilus B Conjugate And Hepatitis B Vaccine"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 63361-243 | VAXELIS | diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine |
| 63361-245 | VAXELIS | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine |
Trademark Results [VAXELIS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VAXELIS 88276439 not registered Live/Pending |
MCM VACCINE CO. 2019-01-25 |
 VAXELIS 87177140 not registered Live/Pending |
MCM VACCINE CO. 2016-09-20 |
 VAXELIS 76059220 not registered Dead/Abandoned |
Connaught Technology Corporation 2000-05-30 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.